Sapacitabine is under clinical development by Cyclacel Pharmaceuticals and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Sapacitabine’s likelihood of approval (LoA) and phase transition for Refractory Acute Myeloid Leukemia took place on 06 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 06 Jun 2022 increased Sapacitabine’s LoA and PTSR for Relapsed Acute Myeloid Leukemia.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Sapacitabine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Sapacitabine overview

Sapacitabine is under development for the treatment of relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), breast cancer, ovarian cancer and pancreatic cancer. It is administered through oral route. Sapacitabine is pyrimidine analogue prodrug with potential antineoplastic activity. Sapacitabine target DNA polymerase and acts through a dual mechanism, interfering with DNA synthesis. It is based on genomic technology. The drug candidate was also under development for the treatment of non-small cell lung cancer (NSCLC), cutaneous T cell lymphoma (CTCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Cyclacel Pharmaceuticals overview

Cyclacel Pharmaceuticals (Cyclacel) is a biopharmaceutical company that develops oral therapies. The company develops small molecule drugs that target various phases of cell cycle control for the treatment of cancer and other serious diseases. Its products include sapacitabine, seliciclib, PLK inhibitor and CDK inhibitor. Cyclacel’s sapacitabine is the drug candidate used to treat the patients with acute myeloid leukemia. Cyclacel seliciclib is an orally available, cyclin dependent kinase inhibitor. It offers products for the treatment of anti-infective, autoimmune, cardiovascular, ophthalmic and other non-oncology indications. The company operates in the US and the UK. Cyclacel is headquartered in Berkeley Heights, New Jersey, the US.

Quick View Sapacitabine LOA Data

Report Segments
  • Innovator
Drug Name
  • Sapacitabine
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.